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PLEGIOX Heat Exchanger with Cardioplegia

Maquet Cardiopulmonary AG · Model CHX 30, Non-coated, Sterile · UDI-DI 04037691180038

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510(k) clearances

4,355

Adverse events (253 deaths)

Recalls

Facilities

Description

The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.

Recalls

Date	Firm	Reason
2025-01-16	Spectrum Medical Inc	Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures.
2024-01-08	Maquet Medical Systems USA	Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resultin
2024-01-08	Maquet Medical Systems USA	Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resultin
2023-06-30	Cardiac Assist, Inc	Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
2021-03-22	QURA S.R.L.	Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US
2020-08-07	Maquet Cardiovascular Us Sales, Llc	Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the i
2020-03-06	Cardiac Assist, Inc	Failure to prime due to an assembly error
2020-03-06	Cardiac Assist, Inc	Failure to prime due to an assembly error
2020-03-06	Cardiac Assist, Inc	Failure to prime due to an assembly error
2020-03-06	Cardiac Assist, Inc	Failure to prime due to an assembly error

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.